510(k) K902193
K902193 is an FDA 510(k) premarket notification submitted by Kevtek Medical Products, Inc. for the device "KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Kevtek Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1991
- Date Received
- May 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type